Cleaning Validation Engineer

Hyde Engineering Consultants•Raleigh, NC

37d•Hybrid

About The Position

The Cleaning Validation Engineer is responsible for cleaning and process engineering and validation in the biotech and pharmaceutical industries. This individual will generate, execute, and report on testing for multiple phases of commissioning and qualification. The position involves post cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility. Experience in CIP/COP and manual cleaning validation activities is required. Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred. Experience Developing documents and SOPs and prepare reports is required. Must have experience analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures. Generate and resolve protocol discrepancies or deviations. Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation. Train operations staff on protocols, procedures and technical details related to systems or processes. Organize, schedule and track validation projects in order to meet client requirements and agreed timelines. Hands-on experience with the following systems: CIP systems, SIP systems, cabinet washers, COP, manual cleaning is required. Experience with sampling techniques. Experience with development of manual cleaning protocols for Tablet press equipment is highly preferred. Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position. Experimental design and problem solving skills are preferred. Strong organizational skills and demonstrated ability to manage projects to completion are highly desired. Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred. Qualifications: Strong problem solving and decision making skills Ability to understand and extract necessary information from technical documents Ability to handle complex projects Takes initiative to help drive projects forward and develop contingency plans when applicable Ability to work on cross-functional project teams Able to effectively manage workload and prioritize activities Excellent verbal and written communication skills Proven ability to review, interpret and make scientific conclusions and recommendations based on data Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals Effectively work within a team environment and interface with peers, management, etc. Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint and Visio. At Hyde Engineering + Consulting, we are an employee-owned firm comprised of industry experts looking to make a meaningful impact for our biopharmaceutical and pharmaceutical clients around the world. We are uniquely positioned in the marketplace to provide solutions to support full-cycle project delivery starting with an optimized cleaning program developed by Hyde's ISO-90001 certified CORE Lab. This work segues into state-of-the-art engineering, commissioning and qualification of facilities and equipment. As we continue to grow our operations around the world, we are hiring engineers and consultants who take ownership in their professional work as well as ownership in the long-term success of Hyde. Our owners embody an entrepreneurial spirit, have diverse perspectives and a passion for learning while simultaneously cultivating lasting client relationships. You will find these values reflected in our company: Family Integrity Friendship Wisdom Adventure Hyde Engineering + Consulting is an equal opportunity, affirmative action employer. #LI-JS1 #LI-Hybrid #Associate

Requirements

Experience in CIP/COP and manual cleaning validation activities is required.
Hands-on experience with the following systems: CIP systems, SIP systems, cabinet washers, COP, manual cleaning is required.
Experience with sampling techniques.
Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position.
Strong problem solving and decision making skills
Ability to understand and extract necessary information from technical documents
Ability to handle complex projects
Takes initiative to help drive projects forward and develop contingency plans when applicable
Ability to work on cross-functional project teams
Able to effectively manage workload and prioritize activities
Excellent verbal and written communication skills
Proven ability to review, interpret and make scientific conclusions and recommendations based on data
Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals
Effectively work within a team environment and interface with peers, management, etc.
Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint and Visio.

Nice To Haves

Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred.
Experience Developing documents and SOPs and prepare reports is required.
Must have experience analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures.
Experience with development of manual cleaning protocols for Tablet press equipment is highly preferred.
Experimental design and problem solving skills are preferred.
Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.
Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred.

Responsibilities

cleaning and process engineering and validation in the biotech and pharmaceutical industries
generate, execute, and report on testing for multiple phases of commissioning and qualification
post cleaning validation monitoring
cleaning cycle development
cleaning validation in a cGMP facility
troubleshooting CIP system failures
optimizing CIP/COP systems including manual processes and CIP equipment
developing CIP/COP Cycles
Developing documents and SOPs and prepare reports
analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures
Generate and resolve protocol discrepancies or deviations
Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation
Train operations staff on protocols, procedures and technical details related to systems or processes
Organize, schedule and track validation projects in order to meet client requirements and agreed timelines